Sanofi and Eli Lilly and Co. have entered a licensing agreement to pursue regulatory approval of over-the-counter Cialis, a medication for erectile dysfunction (ED).


Sanofi, Eli Lilly, licensing agreement, over-the-counter Cialis, Cialis OTC, erectile dysfunction, ED, tadalafil, Vincent Warnery, David Ricks






































































































































































































































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Sanofi, Lilly team up to bring Cialis over the counter

May 29th, 2014

PARIS and INDIANAPOLIS – Sanofi and Eli Lilly and Co. have entered a licensing agreement to pursue regulatory approval of over-the-counter Cialis, a medication for erectile dysfunction (ED).

Currently, Cialis (tadalafil) is available by prescription only worldwide. The companies said Wednesday that under the agreement, Sanofi acquires the exclusive rights to apply for approval of Cialis OTC in the United States, Europe, Canada and Australia.

Sanofi also holds exclusive rights to market Cialis OTC after its receipt of all necessary regulatory approvals. And, if the drug is approved, Sanofi expects to provided Cialis OTC after expiration of certain patents. Terms of the licensing agreement weren't disclosed.

"This agreement provides us with an opportunity to work with Lilly, a leader in men's health, to transform how this important medicine is offered to millions of men throughout the world," stated Vincent Warnery, senior vice president of Sanofi's Global Consumer Healthcare Division. "The opportunity to forge an industry-leading partnership that adds to Sanofi Consumer Healthcare's leading portfolio and successful track record of over-the-counter switches reinforces consumer health care as a major growth platform for Sanofi."

Cialis was first approved by the European Medicines Agency in 2002 and then by the U.S. Food and Drug Administration in 2003 for the treatment of ED. The drug has received approval in more than 120 countries for indications that vary by country.

Cialis reached $2.16 billion in worldwide sales last year and has garnered total global sales of more than $14 billion since its launch. To date, more than 45 million men worldwide have been treated with Cialis.

"Millions of men worldwide trust Cialis to treat ED. We are pleased to work with Sanofi to pursue a path that could allow more men who suffer from ED to obtain convenient access to a safe and reliable product without a prescription," commented David Ricks, senior vice president at Lilly and president of Lilly Bio-Medicines. "Switching a medicine to over the counter is a highly regulated process that is data-driven and scientifically rigorous. Together with Sanofi, we look forward to working closely with regulatory authorities to define the proper actions and necessary precautions to help patients use over-the-counter Cialis appropriately."

Cialis tablets are taken to treat ED, the signs and symptoms of benign prostatic hyperplasia (BPH), and both ED and BPH signs and symptoms. The companies said Cialis is the only PDE-5 inhibitor treatment that offers men a choice in treating ED: Cialis for use as needed and Cialis for once-daily use.

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